Hepatitis A

Hepatitis A and Hepatitis A Vaccine

The following information is provided to as a public service by the National Vaccine Information Center to help you understand the disease hepatitis A and the hepatitis A vaccine so you can make an informed decision regarding the use of this vaccine. This information is not intended to serve as medical advice but as background information that you can use to educate yourself and ask your doctor questions.

NVIC encourages you to become fully informed about hepatitis A and hepatitis A vaccine and speak with one or more trusted health care professionals before making a decision about vaccination.

Whenever making a major health care decision for yourself or your child, especially one that involves use of a pharmaceutical product such as a vaccine, obtaining information from many different sources and consulting health care professionals you trust is important.

Becoming an informed health care consumer will empower you to ask your doctor questions and help you to take control of your health choices. If your doctor does not support your informed health choices, consider consulting another doctor who will work as a partner with you in making important health care decisions for yourself or your child.

As of September 1, 2015, there had been 103 claims filed in the federal Vaccine Injury Compensation Program (VICP) for injuries and deaths following Hepatitis A vaccination, including 6 deaths and 97 serious injuries.

Using the MedAlerts search engine, as of September 1, 2015 there had been 3,450 serious adverse events reported to the Vaccine Adverse Events Reporting System (VAERS) in connection with Hepatitis A containing vaccines since 1990. Over 35% of those serious Hepatitis A vaccine-related adverse events occurring in adults between seventeen and forty-four years old. Of these Hepatitis A-vaccine related adverse event reports to VAERS 114 were deaths, with 34% of the deaths occurring in children under three years of age.

If you feel that your health problems are related to the Hepatitis A it is your right to file for compensation. To learn more about the VICP and how to file a claim, please visit our injury compensation webpage.

What Is Hepatitis A?

Hepatitis A is a viral disease of the liver that is contracted through contact with, or swallowing of human fecal waste, generally through eating or drinking contaminated food and/or water.

Hepatitis A thrives in areas with poor sanitation and is spread when people eat or drink something that has been contaminated with human body waste products. Children often show no symptoms and the disease is more serious in adults.

Hepatitis A involves the liver and about 15 percent of people who get it will have symptoms of jaundice (yellowing of the skin and eyes), fatigue, stomach pain, nausea, diarrhea and fever that comes and goes for 6 to 9 months. Most children and adults recover without complications and will have lifelong immunity to the disease.

The jaundice that turns the skin and eyes yellow is common in adults but rare in children. Most children under the age of 6 years do not get sick from the infection, but can spread it to older children and adults.

The incubation period for hepatitis A is 15 to 45 days, or about 4 weeks. It is possible for the virus to begin shedding through the stool of the infected person from 2 weeks before to 1 week after the onset of the disease.

Hepatitis A is spread almost exclusively by the fecal-oral route and is most often associated with poor sanitation and hygiene, and overcrowded living conditions.

It also is associated with lower socioeconomic status, certain sexual practices, and injected drug use. However, outbreaks of hepatitis A have also occurred in restaurants, daycare centers, nursing homes, and other institutions and community settings.

Some outbreaks of hepatitis A have been traced to contaminated food, water, milk, frozen raspberries and strawberries, and shellfish.

Among adults with identified risk factors, the majority of cases are among men who have sex with men, persons who use illegal drugs, and international travelers. Because transmission of hepatitis A during sexual activity probably occurs because of fecal-oral contact, measures typically used to prevent the transmission of other STDs (e.g., use of condoms) do not prevent hepatitis A transmission.

Hepatitis A infections also have been linked to children adopted from certain countries.

Is Hepatitis A a Communicable Disease – Can It Be Spread Person-to-Person?

Yes, hepatitis A is spread person-to-person. However, hepatitis A is not transmitted through casual contact, such as shaking hands, hugging or coughing.

It is rarely blood-borne, although several outbreaks have been identified in those who have been injected with blood clotting factor concentrates.

Poor personal hygiene can increase the chances of spreading hepatitis A. That is why frequent hand washing with soap and water, particularly after using the bathroom, changing a diaper, and before preparing or eating food, is very important in preventing the spread of hepatitis A.

It also has been identified as a risk factor in daycare centers and intensive care neonatal units.

Travel to Third World countries, where hepatitis A is more prevalent, also is an identified risk factor for getting this infection.

How Do You Treat Hepatitis A?

There is no treatment for hepatitis A and 99 percent of persons who get infected recover without treatment. Therapy, if any, focuses on rehydration and nutritional support to replace what is lost from vomiting and diarrhea.

Once You Have Had Hepatitis A Can You Get It Again?

According to Harrison’s Principles of Internal Medicine1, once you have recovered completely from hepatitis A, antibodies to the disease will give you lifelong immunity, and will prevent you from getting it again. However, blood tests for hepatitis A will always remain positive.

Can Hepatitis A Cause Injury and/or Death?

There is a gap in medical knowledge in terms of predicting who will have a mild case of hepatitis A and who will have a serious case that could lead, rarely, to death.

According to the CDC, most previously healthy patients with hepatitis A recover completely but a small number of patients will experience a relapse a few weeks or months after an apparent recovery. In rare instances hepatitis A may cause liver problems for several months without progressing to chronic liver disease.

What Is the Incidence of Hepatitis A in the US?

Historically, acute hepatitis A rates have varied cyclically, with nationwide increases in the U.S. every 10–15 years. The national rate of acute hepatitis A has declined 92 percent since the last peak in 1995, just before a vaccine for Hepatitis A was introduced.

During 1987–1997, an average of 28,000 cases of hepatitis A occurred per year in the United States. In 2007, a total of 2,979 acute symptomatic cases of hepatitis A were reported.

In 2007 (the latest year for which data are available) 18 percent of all cases of Hepatitis A were attributable to international travel. Approximately 85 percent of all travel-related cases were associated with travel to Mexico and to Central or South America.

In this country, the Centers for Disease Control (CDC) reports that 29.1 percent to 33.5 percent of Americans have evidence of past infection with hepatitis A and are immune.

Waterborne outbreaks, though infrequent, are usually associated with sewage-contaminated, or inadequately treated, water.

Hepatitis A is rarely fatal. While the CDC’s Vaccine Information Statement for the hepatitis A vaccine (last updated 2006) says that 3 to 5 people per 1,000 infected will die from the disease, a 2009 report from the CDC shows that no deaths from this disease have been reported in at least 10 years.

What Is the Incidence of Hepatitis A in the Rest of the World?

Hepatitis A occurs worldwide sporadically and tends to cycle 2 every 5 to 20 years within populations, often peaking in late autumn and early winter in temperate climates. Worldwide, HAV infections account for an estimated 1.4 million cases annually.

What is the Hepatitis A Vaccine?

The ACIP has approved three inactivated , injectable vaccines for hepatitis A: Havrix; Twinrix; and Vaqta.

Havrix contains viral antigen and aluminum hydroxide (an adjuvant) with amino acid supplement in a phosphate buffered saline solution, polysorbate 20 (an emulsifier). The virus is propagated in human diploid cells. It also has neomycin (an antibiotic) in it. It does not contain preservatives.

The tip cap and the plunger on the syringe have latex in them.

Twinrix is a combination vaccine that is intended to protect against both hepatitis A and hepatitis B. It is manufactured using MRC-5, which was derived from a cell line that was developed in 1966 from lung tissue taken from a 14-week aborted fetus and contains viral antigens, yeast, aluminum phosphate, aluminum hydroxide, neomycin and formalin (formaldehyde and water). It does not contain preservatives.

It is formalin inactivated and adsorbed onto amorphous aluminum hydroxyphosphate sulfate. It also has traces of bovine albumin and formaldehyde. It does not contain preservatives. The tip cap and the plunger on the syringe have latex in them.

Who Does the Advisory Committee on Immunization Practices Recommend Take This Vaccine?
As of 2010 the ACIP recommends that all infants age 1 to 2 years should receive two doses of hepatitis A vaccine spaced at least 6 months apart. Children not fully vaccinated by age 2 years can be vaccinated at subsequent visits.

Two doses of the vaccine also are recommended for older children who live in areas where vac­cination programs target older children, who are at increased risk for infection, or for whom immunity against hepatitis A is desired.

The vaccine is not approved for children under age 1.

NVIC Note: There are some doctors who either administer vaccines singly or limit the numbers of vaccines given simultaneously. You may want to consider discussing scheduling options with your doctor.

Is the Hepatitis A Vaccine Mandated in State Laws?

By 2010, at least 10 states have mandated this vaccine for select groups of people, from food handlers to daycare attendees to kindergarten students. For more information about which vaccines your state mandates, go here on the NVIC website.

Who Should NOT Get This Vaccine?

According to the vaccine manufacturers and the CDC, certain persons should not get hepatitis A vaccine, or should postpone getting it. Those persons are:

Anyone who has ever had a severe (life-threatening) allergic reaction to a previous dose of hepatitis A vaccine should not get another dose.

Anyone who has a severe (life threatening) allergy to any vaccine component should not get the vaccine. Tell your doctor if you have any severe allergies. All hepatitis A vaccines contain aluminum and some hepatitis A vaccines contain 2-phenoxyethanol (a chemical preservative).

Anyone who is moderately or severely ill at the time the shot is scheduled should probably wait until they recover. Ask your doctor or nurse. People with a mild illness can usually get the vaccine.

NVIC Note: Some doctors only vaccinate children who are healthy and are not sick at the time of vaccination with a coinciding viral or bacterial infection. If you do not want your acutely ill child vaccinated and your doctor disagrees with you, you may want to consider consulting one or more other trusted health care professionals before vaccinating.

Tell your doctor if you are pregnant. The safety of hepatitis A vaccine for pregnant women has not been determined. According to the package inserts, reproduction studies have not been conducted with any of the hepatitis A vaccines.

It is also not known whether any of the hepatitis A vaccines can cause fetal harm when administered to a pregnant woman or whether the vaccines can affect reproduction capacity. All of the vaccine makers advise that their hepatitis A vaccine be given to pregnant women only if clearly indicated.

All three vaccine makers also report that it is not known whether their vaccines are excreted in human milk. Therefore, they all urge that caution should be exercised when administering the hepatitis A vaccine to a woman who is breastfeeding.

According to the GlaxoSmithKline manufacturer’s package insert, TWINRIX should be given with caution in persons with bleeding disorders such as hemophilia or thrombocytopenia and in persons on anticoagulant therapy.

Havrix carries a warning that severe allergic or anaphylactic (shock) reactions could be possible from the latex in the syringe cap and tip.

How Effective Is the Hepatitis A Vaccine?

All three Hepatitis A vaccine package inserts warn that the vaccines may not, or cannot, prevent or treat the disease in someone who is already infected or has been infected with hepatitis A. They also warn that some immunocompromised individuals may not be fully protected, either.

Can the Hepatitis A Vaccine Cause Injury and/or Death?

There is a gap in medical knowledge in terms of predicting who will have an adverse reaction to the hepatitis A vaccine and who will not.

However, reading the manufacturer’s product package inserts (see below) under “contraindications, warnings and precautions, and adverse reactions,” will help you weigh the vaccine’s benefits and risks before making a decision for yourself or your child.

Within the hepatitis A manufacturers’ vaccine package inserts, some of the adverse events reported ranged from fever, to nausea and loss of appetite, to dizziness, and neuromuscular symptoms, including Guillian Barre Syndrome.

According to the CDC, some of the other risks and side effects from this vaccine are:

Mild problems

Soreness where the shot was given (about 1 out of 2 adults, and up to 1 out of 6 children)

Headache (about 1 out of 6 adults and 1 out of 25 children)

Loss of appetite (about 1 out of 12 children)

Tiredness (about 1 out of 14 adults)

If these problems occur, they usually last 1 or 2 days.

Severe problems

Serious allergic reaction, within a few minutes to a few hours of the shot (very rare).

Vaccine Information Statements (VIS) are created by federal health officials at the Centers for Disease Control.

They are printed information sheets that briefly describe diseases and vaccines, and are mandated by federal law (the National Childhood Vaccine Injury Act of 1986) to be given to a person receiving a government recommended or mandated vaccine, or to the parent or legal guardian of that person beforeadministration of the vaccine(s).

Why Do I Need to Read Both the Vaccine Manufacturer Product Information Package Insert and the Vaccine Information Statement Before I Make a Vaccine Decision?

Vaccine Information Statements are just one or two pages long and do not contain the detail that manufacturer product information package inserts do.

Reading the package insert will help you learn exactly what components, including preservatives, adjuvants and other additives, are contained in the vaccine and how the vaccine is made.

The package insert will also give you more complete information about (1) reported adverse health outcomes, including injuries and deaths reported in pre-licensure clinical trials and post-marketing surveillance; and (2) reasons why your child should not use a particular vaccine (contraindication) according to the vaccine’s manufacturer.

You can ask your physician (or vaccine administrator) for the manufacturer product information package insert and the CDC’s Vaccine Information Statement (VIS) in advance of the date your child is scheduled to be vaccinated. You can also read the manufacturer product information inserts for rotavirus vaccine here on NVIC.org.

Read the Hepatitis A Vaccine Information Statements Prepared by the CDCfor the single vaccine here.

Should Hepatitis A Vaccine Be Mandated?
Hepatitis A does not cause chronic, long term infection and very rarely causes death. Infection with hepatitis A gives a person lifelong immunity and, in some populations around the world, close to 100 percent of all inhabitants have antibodies to hepatitis A.

The CDC states that persons at high risk for hepatitis A are household and sexual contacts of infected persons; drug users; persons traveling to countries where hepatitis A is common; and persons living in regions where there are "consistently increased rates of hepatitis A."

The best tool for prevention of hepatitis A is to wash your hands with soap and water after using the bathroom, changing a diaper or preparing and eating food.
While the National Vaccine Information Center (NVIC) supports the availability of hepatitis A vaccine for all who choose to use it, NVIC opposes the mandated use of hepatitis A vaccine for the following reasons:

Hepatitis Does Not Cause Chronic Infection and Rarely Causes Death: Hepatitis A has a mortality rate of less than one percent (0.6) and over 70 percent of deaths occur in adults over the age of 49. Almost everyone who gets hepatitis A recovers from it without any treatment. Plus, it is so rarely fatal that the CDC does not show a record of deaths from it some years.

Hepatitis A Gives Lifelong Immunity But the Vaccine Does Not: Children often show no symptoms if they get hepatitis A and then develop lifelong immunity to the infection, but nobody knows how long vaccine-induced immunity will last. (All vaccines give only temporary immunity).

Child-to-Child Transmission in School is Rare: According to the CDC, "Child-to-child disease transmission [of hepatitis A] within the school setting is uncommon."

Hepatitis A Vaccine Can Cause Reactions: The vaccine can cause unpleasant or even health- or life-threatening conditions, such as Guillian-Barre Syndrome (see vaccine side effects under “Can the Hepatitis A Vaccine Cause Injury and/or Death”).

In clinical trials conducted by SmithKline Beecham (now GlaxoSmithKline), between 9 and 14 percent of adults and children reported headache after vaccination and between 21 and 56 percent had local reactions. Up to 10 percent had fever, fatigue, malaise, nausea and loss of appetite.

Since the vaccine was licensed in 1996, there have been thousands of serious adverse events to this vaccine reported to the Vaccine Adverse Event Reporting System (VAERS), including deaths.

Vaccine Components Not Adequately Evaluated: Hepatitis A vaccines manufactured by (Glaxo) SmithKline (Beecham) and Merck are made using human fetal diploid (lung) cells to propagate the virus.

HAVRIX contains aluminum as well as phenoxyethanol as a preservative. Traces of formalin and residual fetal human diploid cellular proteins are also present.

VAQTA contains aluminum and small amounts of non-viral protein, DNA, bovine albumin, and formaldehyde. Both HAVRIX and VAQTA manufacturer package inserts say they have "not been evaluated for its carcinogenic or mutagenic potential, or its potential to impair fertility."

No Long Term Studies: There were no long term studies to evaluate whether hepatitis A vaccine given alone or in combination with other vaccines is associated with chronic illness or disability, such as the development of diabetes, asthma, seizure disorders, learning disabilities, ADHD, or autism.

The Merck product insert for VAQTA states "Subjects were observed during a 5-day period for fever and local complaints and during a 14-day period for systemic complaints." According to the World Health Organization, “Planning for large-scale immunization programs should involve careful economic evaluations and consider alternative or additional prevention methods, such as better sanitation and health education for improved hygiene.

“Whether or not to include the vaccine in routine childhood immunizations depends on the local context, including the level of risk for children.

Has your doctor or a vaccine provider refused to report a serious health problem after hepatitis A vaccination to the federal Vaccine Adverse Event Reporting System (VAERS), or discouraged you from reporting a vaccine reaction you or your child experienced?

Have you been threatened or harassed for making vaccine decisions which do not conform with government recommendations or state mandates?